Effects of Photobiomodulation on the Innate Immune System of Neonates and Infants Diagnosed With Acute Respiratory Sintitial Virus Bronchiolitis - Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Innate Immunological Markers
研究概览
简要总结
The innate immune response of children with acute viral bronchiolitis (AVB) caused by respiratory syncytial virus (RSV) in the acute phase and in the resolution phase, is marked by variations in inflammatory and anti-inflammatory mediators, where in the acute phase there is recruitment and activation of multiple cells of the immune system, with consequent increase in the expression of pro-inflammatory mediators. Evidence indicates that there is a considerable increase in tumor necrosis factor-alpha (TNF) , interleukine 6 (IL6), interleukine 1-beta, interleukine 8 (IL8) interleukine 10 (IL10), exposing to IL6, IL8 and IL-10 positively correlated with AVB severity. There are already reports that the transcutaneous application of photobiomodulation (PBM) reaches the lungs, producing positive responses in respiratory pathologies, both acute and chronic . Thus, PBM caused by the use of low-level laser may be a favorable resource to be used in the area of respiratory physiotherapy, specifically in neonatology and pediatrics, since there are studies in both experimental and human models that prove its action on lung cells, acting to reduce airway edema, reduce neutrophil migration to lung tissue and synthesize pro-inflammatory cytokines TNFalpha, IL6 and IL-10. In addition, it is a portable, practical, quick application, with minimal contraindications and possibly better tolerated by the neonatal and pediatric population.
详细描述
Acute Viral Bronchiolitis (AVB) is the most common disease of the lower respiratory tract in children, being one of the major causes of hospitalization in children under two years of age, especially in winter. It is characterized by inflammation, edema, and necrosis of cells of the small airways epithelium, with increased mucus secretion and bronchospasm. Among the most common pathogens for the development of AVB are rhinovirus, influenza A and B, parainfluenza, metapneumovirus, adenovirus, however, the most common and responsible for 70% of AVB in children under two years of age is respiratory syncytial virus (RSV). RSV is highly contagious and infectious, accounting for 2-3% of the hospitalization of infected children, and there is a seasonal variation in RSV infection levels, which are higher during the winter in temperate regions, and this occurs because low temperatures and high humidity favor the proliferation of the virus.
RSV is transmitted through the air in contact with the nasal epithelium, mouth, eyes, or contaminated surfaces, and the incubation time is three to eight days. As soon as the virus reaches the nose or mouth, it begins to infect the epithelial cells of the upper respiratory tract, then progresses to the lower airways reaching the bronchioles where it replicates more easily, thus developing bronchiolitis. Inflammation and obstruction of the bronchioles then occurs, resulting in reduced airflow in the small caliber airways, altering the ability to exhale, which leads to hyperinflation, increased mucus production, atelectasis and wheezing. Immunopathology occurs through the expression of pro-inflammatory cytokines with subsequent perivascular and peribronchial infiltration of mononuclear cells, mostly neutrophils and lymphocytes, triggering an unbalanced response between T helper cells 1 and 2.
In addition to AVB, RSV infection can lead to pneumonia in addition to the possibility of later development of wheezing and asthma, so there is growing concern about how RSV infections in the first months of life can lead to the development of chronic lung diseases. in addition to being considered the second pathogenic agent causing death in children under one year of age.
The inability of the innate immune system of neonates and children to fight RSV infection and its serious consequences makes the development of new prevention and treatment strategies a priority.
To meet this need, notable advances have been made in recent years in relation to low-level laser PBM applied to lung diseases. PBM is a non-invasive, adverse-effect-free, accessible, and well-tolerated resource for patients diagnosed with pulmonary diseases such as chronic obstructive pulmonary disease, COVID-19 and asthma. Many effects are attributed to PBM and one of the main ones is its antioxidant and anti-inflammatory effects at the cellular level. From the penetration of the photon into the tissue where it interacts with intracellular molecules and initiates a series of changes in its functioning, including membrane permeability and cellular metabolism, regulating antioxidative defenses and reducing oxidative stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 2 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of AVB due to RSV confirmed on hospital admission examination
排除标准
- •Diagnosis of congenital or acquired heart disease;
- •Pulmonary malformations;
- •Use of any number of doses of palivizumab or another immunobiological agent;
- •Present any "new pathology" during treatment with FBM;
- •Cancer of any histology;
- •Skin lesion near the application sites;
- •Desire to drop out of study.
结局指标
主要结局
Innate Immunological Markers
时间窗: 4th day of hospitalization and 8th or discharge day
Due to the increase in nasotracheal secretion caused by AVB, nasotracheal aspiration is usually a routine procedure because it is often necessary to perform it to maintain the pervious airways, since in some cases children cannot properly manage the secretion. Thus, this procedure will be used to collect secretion on the first, fourth and eighth days of care, stored in a -80°C freezer and later sent for laboratory analysis of pro-inflammatory cytokines such as: tumor necrosis factor alpha (TNF), interleukin 6 (IL6), interleukin 1-beta, and anti-inflammatory interleukin 10 (IL10). Cytokine analysis will be performed by flow cytometry using the BD™ Cytometric Bead Array (CBA) kit.
次要结局
- Overall(1st day of hospitalization through 8th or discharge day)
- Severity of AVB(1st day of hospitalization through 8th or discharge day)
